Amiodarone Impurity 16 CAS 318267-30-0

Description

The occurrence of Amiodarone Impurity 16 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Amiodarone Impurity 16 (CAS 318267-30-0, C25H29I2NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Amiodarone Impurity 16 (C25H29I2NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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